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Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021)

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ClinicalTrials.gov Identifier: NCT02653118
Recruitment Status : Active, not recruiting
First Posted : January 12, 2016
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
Protocol V503-021 is a long-term follow-up study of the V503-001 base study (NCT00543543) to evaluate the safety, immunogenicity, and long-term effectiveness of V503 vaccine in preventing cervical cancer and related precancers caused by human papillomavirus (HPV) types 16, 18, 31, 33, 45, 52, and 58. Because of the high retention of V503-001 participants from the Nordic countries, and the highly efficient screening and surveillance system there, study V503-021 will evaluate only participants from V503-001 sites in Denmark, Norway, and Sweden. The hypothesis being tested is that V503 vaccine will remain effective for at least 14 years after the start of vaccination.

Condition or disease Intervention/treatment
Cervical Cancer Vulvar Cancer Vaginal Cancer Genital Warts Human Papillomavirus Infection Biological: V503 Biological: GARDASIL

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Study Type : Observational
Estimated Enrollment : 4453 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Registry-Based Extension of Protocol V503-001 in Countries With Centralized Cervical Cancer Screening Infrastructures to Evaluate the Long-Term Effectiveness, Immunogenicity, and Safety of Multivalent Human Papillomavirus (HPV) L1 Virus- Like Particle (VLP) Vaccine as Administered to 16- to 26- Year- Old Women
Actual Study Start Date : January 22, 2016
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Group/Cohort Intervention/treatment
Cohort 1: V503 in the Base Study
Participants received the selected dose formulation of V503 (0.5 mL in a 3-dose regimen) from a Denmark, Norway, or Sweden site in the base study (V503-001, NCT00543543). No study vaccination will be administered in study V503-021.
Biological: V503
Cohort 2: GARDASIL in the Base Study
Participants received GARDASIL (0.5 mL in a 3-dose regimen) from a Denmark, Norway, or Sweden site in the base study (V503-001, NCT00543543) and were offered the selected dose formulation of V503 (0.5 mL in a 3-dose regimen) at the conclusion of the base study. V503 vaccination was voluntary and not a condition for inclusion in Cohort 2. No study vaccination will be administered in study V503-021.
Biological: V503
Biological: GARDASIL



Primary Outcome Measures :
  1. Combined Incidence of HPV Type 16, 18, 31, 33, 45, 52, or 58-related Cervical Intraepithelial Neoplasia (CIN) Grades 2 or 3, Adenocarcinoma In Situ (AIS), and Cervical Cancer [ Time Frame: Up to 16 years after vaccination in V503-001 base study ]


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Ages Eligible for Study:   16 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants in the V503-021 long-term follow-up study received either the selected dose formulation of V503 or GARDASIL in the V503-001 (NCT00543543) base study
Criteria

Inclusion Criteria:

  • Randomized into the V503-001 (NCT00543543) study from a Denmark, Norway, or Sweden site and participated in the study by receiving either the selected dose formulation of V503 or GARDASIL
  • Age 16 to 26 years at the time of enrollment in study V503-001
  • Agrees to allow passive follow-up, analysis of biopsy specimens, future contact from the National Registry Study Centers, and serum collection

Exclusion Criteria:

  • There are no exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653118


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

Publications:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02653118     History of Changes
Other Study ID Numbers: V503-021
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Uterine Cervical Diseases
Vaccines
Papillomavirus Infections
Condylomata Acuminata
Uterine Cervical Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Vulvar Diseases
Vaginal Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Warts
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Immunologic Factors
Physiological Effects of Drugs